FDA Registration
Active
🇩🇪 Germany
PERI-LOC PERIARTICULAR AND VARIABLE- ANGLE LOCKED PLATING (VLP) SYSTEMS
Reg #: 8010764
·
FEI: 3002465897
·
Expires 2025
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SMITH & NEPHEW ORTHOPAEDICS, GMBH
- Registration Number
- 8010764
- FEI Number
- 3002465897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALEMANNENSTRASSE 14
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K213126
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
US Agent
- Business Name
- SMITH & NEPHEW, INC.
- Contact Name
- Lisa Ewing
- Address
- 2875 Railroad St
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
- [email protected]
- Phone
- 412 4199765
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2022-11-07 |
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | Class 2 | Orthopedic | No | 2022-11-07 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-11-07 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2022-11-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-11-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-11-07 |
Proprietary Names
PERI-LOC PERIARTICULAR AND VARIABLE- ANGLE LOCKED PLATING (VLP) SYSTEMS
CANNULATED SCREWS
D-RAD PLATING SYSTEM
EVOS PLATING SYSTEMS
CHS COMPRESSION HIP SCREW
TC-100 SCREW AND PLATING SYSTEM
CONQUEST FN
CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM
Establishment Types
Manufacture Medical Device